Premature Infants in Need of Transfusion (PINT)

Status Completed

Clinical Trial Summary

Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).

Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.

Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00182390
Study type	Interventional
Source	McMaster University
Contact
Status	Completed
Phase	Phase 3
Start date	February 2001
Completion date	November 2005

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See also
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Completed	`NCT01539356` - Hepcidin Levels in Preterm Infants	N/A
Completed	`NCT02101086` - Autologous Cord Blood Transfusion in Preterm Infants	N/A
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Terminated	`NCT01735552` - Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates	N/A
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Not yet recruiting	`NCT06220461` - Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants	N/A
Withdrawn	`NCT01121328` - Autologous Umbilical Cord Blood Transfusion for Preterm Neonates	Phase 1
Completed	`NCT01393496` - Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants	Phase 4
Completed	`NCT00457990` - Neurodevelopment After Early Iron Supplementation	N/A